A Study to Assess the Efficacy of Cerebellar IMRT Combined With Cerebral SRS in Patients With Brain Metastases

NCT05477316 | Unknown DMC FDA Device

• 1 other identifier: 0930-20
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

A single-arm pilot study, to assess the efficacy of cerebellar IMRT combined with cerebral SRS in patients with brain metastases that are predominantly in the posterior fossa - a novel treatment approach

Conditions

Brain Metastases; Posterior Fossa Lesion; Cerebral Lesion

Keywords

Brain Metastases; Posterior Fossa; Cerebellum; Cerebral Lesion; Cerebrum

Outcome Measures

Primary Outcomes (1)

• Brain control: Central Nervous System (CNS)- Progression Free Survival (PFS)

  Metastatic brain lesions treated with IMRT/SRS will be tracked and measured using MRI. Disease in the brain and systemically will be assessed by RECIST.

  Change in lesion size in the whole body will be followed and assessed at screen, 2 month after radiation treatment, then every 3 month until the date of first documented progression or date of death from any cause, up to 10 years.

Secondary Outcomes (3)

• Cognitive function

  Change in patient cognitive function will be followed and assessed at screen, 2 month after radiation treatment, then every 3 month, until the date of first documented progression or date of death from any cause, up to 10 years.

• Quality of life (QOL)

  Change in patient QOL will be followed and assessed at screen, 2 month after radiation treatment, then every 3 month, until the date of first documented progression or date of death from any cause, up to 10 years.

• Overall survival (OS)

  Status will be checked at every visit and follow up, until the date of death from any cause, up to 10 years.

Study Arms (1)

Treatment

EXPERIMENTAL

Intensity-modulated Radiation Therapy (IMRT)/VMAT with integrated boost to the cerebellum and metastases and Stereotactic Radiosurgery (SRS) to the cerebral metastases as a novel treatment combination for brain metastases

Radiation: Radiation treatment

Interventions

Radiation treatment RADIATION

Radiation treatment of IMRT to the cerebellum and SRS to the cerebrum

Treatment

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of multiple brain metastasis, predominantly in the posterior fossa: more than 5 metastases in the cerebellum, and less than 10 metastases in the cerebrum, visible on MRI, regardless of tumor origin.
• Provided written informed consent.
• Be male or female and at least 18 years of age on the day of signing informed consent.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
• A minimum life expectancy of at least 3 months
• Female patients:
• Willing to use adequate contraceptive measures until 6 weeks after the final dose of study treatment
• Not breast feeding
• Have a negative pregnancy test prior to the start of dosing if of childbearing potential or have evidence of non-childbearing potential by fulfilling one of the following criteria at screening:
• i. Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments ii. Women under 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with Luteinizing Hormone (LH) and Follicle-Stimulating Hormone (FSH) levels in the post-menopausal range for the institution iii. Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation
• Male patients who are willing to use barrier contraception (i.e. condoms) until 4 months after the final dose of study treatment.

You may not qualify if:

• Prior treatment with Whole brain radiation (WBRT) (previous SRS is allowed for limited, up to 4 metastases, six month or more prior to the study treatment, and the index metastases should be all new)
• An investigational drug within five half-lives of the compound.
• Spinal cord compression unless asymptomatic and stable.
• Leptomeningeal disease.
• Moderate or severe symptomatic brain metastases defined as per Radiation therapy Oncology Group acute morbidity grade 3 to 4.
• Note: Grade 3 refers to neurological findings requiring hospitalization for initial management. Grade 4 refers to serious neurological impairment including paralysis, coma or seizures more than three times per week despite medication and requires hospitalization.
• Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.
• Involvement in the planning and conduct of the study
• Judgement by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Ein Kerem Medical Center

Jerusalem, 9112001, Israel

RECRUITING

Related Publications (21)

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Related Links

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MeSH Terms

Conditions

Brain Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator, oncologist and radiation specialist

Study Record Dates

• First Submitted: December 12, 2021
• First Posted: July 28, 2022
• Study Start: February 11, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 28, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)